Accelerated Degradation Experiment
Conditions
Procedure A: |
30 days exposure at 50 °C and 100% relative humidity. |
Procedure B: |
30 days exposure at 50 °C and 100% relative humidity followed by 4 days at 70 °C and 100% relative humidity. |
Appearance of the substance
The substance, originally in the form of a white or almost white, microcrystalline powder, changes rapidly after procedure A into an orange-brown powder and after procedure B into a viscous dark red-brown liquid.
Gain of moisture
After procedures A and B: 63%
Chromatographic test
Adsorbent: Silica gel F-254
Solution applied to the plate: Substance dissolved in 0.25 N hydrochloric acid.
Solvent system:
n-butanol: .............................6 volumes
acetic acid: ...........................2 volumes
water: ...................................2 volumes
Development conditions: The solvent is allowed to migrate until the front reaches a line 15 cm from the starting line.
Detection: The plate is left in a chromatographic chamber containing some iodine crystals until spots appear.
Results: The chromatogram obtained from the solution of the sample subjected to procedure A in comparison to the chromatogram obtained from the reference solution of epinephrine displays tailing on either side of the main spot indicating a degradation of about 50%.
Conclusion
Epinephrine is subject to strong decomposition under accelerated degradation conditions.
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